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CN112089981A - Implantable Cardiac Defibrillator and External Defibrillator Combination System - Google Patents

Implantable Cardiac Defibrillator and External Defibrillator Combination System Download PDF

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CN112089981A
CN112089981A CN202011069831.6A CN202011069831A CN112089981A CN 112089981 A CN112089981 A CN 112089981A CN 202011069831 A CN202011069831 A CN 202011069831A CN 112089981 A CN112089981 A CN 112089981A
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cardiac defibrillator
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平利川
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    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
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Abstract

本发明公开一种植入式心脏除颤器和体外除颤设备联合系统,植入式心脏除颤器和体外除颤设备;所述植入式心脏除颤器包括处理器、感知模块、治疗模块和通信模块;所述体外除颤设备包括处理器、感知模块、治疗模块和通信模块;所述植入式心脏除颤器的处理器被配置为根据所述感知模块感知到的心电信号诊断是否需要电刺激治疗,所述处理器再使用所述治疗模块对心脏进行电刺激治疗前,使用通信模块对外发送广播消息,该广播消息包含处理器即将实施的治疗信息。上述方案能够将植入式心脏除颤器信息广播给体外除颤设备减少误治疗。

Figure 202011069831

The invention discloses a combined system of implantable cardiac defibrillator and external defibrillation equipment, implantable cardiac defibrillator and external defibrillation equipment; the implanted cardiac defibrillator comprises a processor, a sensing module and a treatment module and a communication module; the external defibrillation device includes a processor, a sensing module, a treatment module and a communication module; the processor of the implantable cardiac defibrillator is configured to diagnose the ECG signal sensed by the sensing module Whether electrical stimulation therapy is required, before the processor uses the therapy module to perform electrical stimulation therapy on the heart, the processor uses the communication module to send a broadcast message to the outside, where the broadcast message contains information about the therapy to be performed by the processor. The above solution can broadcast the information of the implantable cardiac defibrillator to the external defibrillation equipment to reduce wrong treatment.

Figure 202011069831

Description

植入式心脏除颤器和体外除颤设备联合系统Implantable Cardiac Defibrillator and External Defibrillator Combination System

技术领域technical field

本发明属于医疗设备领域,特别涉及对植入式心脏除颤器和体外除颤器的改进。The invention belongs to the field of medical equipment, and particularly relates to the improvement of implantable cardiac defibrillators and external defibrillators.

背景技术Background technique

植入式心脏除颤器被植入患者体内用于预防可能出现的心源性猝死,在患者发生室颤时。患者会晕厥,此时ICD进入诊断状态并根据诊断结果进行相应的治疗。Implantable cardiac defibrillators are implanted in patients to prevent possible sudden cardiac death when the patient develops ventricular fibrillation. The patient will syncope, at which point the ICD enters the diagnostic state and the appropriate treatment is performed according to the diagnosis.

在一些情况下患者晕厥所在的场所有可能会设置体自动外除颤设备(AED), 自动体外除颤设备会分析患者的心电信号并根据分析结果进行治疗。同时患者体内的ICD有可能也正在进行分析和治疗,这样患者有可能同时被体外除颤设备和ICD除颤。同时在患者晕厥时对患者进行体外除颤的急救人员也不知道患者体内ICD的状态。In some cases, an automatic external defibrillation device (AED) may be installed in the place where the patient has syncope, which will analyze the patient's ECG signal and perform treatment based on the analysis result. At the same time, the ICD in the patient may also be analyzed and treated, so that the patient may be defibrillated by the external defibrillation device and the ICD at the same time. At the same time, the emergency personnel who perform external defibrillation on the patient during syncope do not know the state of the ICD in the patient's body.

发明内容SUMMARY OF THE INVENTION

为解决上述技术问题本发明提供一种植入式心脏除颤器和体外除颤设备联合系统。In order to solve the above technical problems, the present invention provides a combined system of an implantable cardiac defibrillator and an external defibrillator.

所述植入式心脏除颤器和体外除颤设备联合系统,包括植入式心脏除颤器和体外除颤设备;所述植入式心脏除颤器包括处理器、感知模块、治疗模块和通信模块;所述体外除颤设备包括处理器、感知模块、治疗模块和通信模块;所述植入式心脏除颤器的处理器被配置为根据所述感知模块感知到的心电信号诊断是否需要电刺激治疗,所述处理器再使用所述治疗模块对心脏进行电刺激治疗前,使用其通信模块对外发送广播消息,该广播消息包含处理器即将实施的治疗信息;The implantable cardiac defibrillator and external defibrillation equipment combined system includes the implantable cardiac defibrillator and the external defibrillation equipment; the implantable cardiac defibrillator includes a processor, a sensing module, a treatment module and A communication module; the external defibrillation device includes a processor, a sensing module, a treatment module and a communication module; the processor of the implantable cardiac defibrillator is configured to diagnose whether the ECG signal is sensed by the sensing module If electrical stimulation therapy is needed, before the processor uses the therapy module to perform electrical stimulation therapy on the heart, the processor uses its communication module to send a broadcast message to the outside world, and the broadcast message contains information about the therapy to be implemented by the processor;

所述体外除颤设备的处理器通过其通信模块接收到所述植入式体除颤设备发送的广播消息后根据广播消息的内容,执行相应的操作。After receiving the broadcast message sent by the implantable body defibrillation device through its communication module, the processor of the external defibrillation device performs corresponding operations according to the content of the broadcast message.

在上述方案中所述植入式心脏除颤器能够在电刺激治疗时向外部广播正在进行治疗的信号,体外除颤设备就能够根据广播消息的内容做出对应的反应,防止在体内除颤设备做治疗时重复治疗造成误治疗。In the above solution, the implantable cardiac defibrillator can broadcast the signal being treated to the outside during the electrical stimulation treatment, and the external defibrillation device can make a corresponding response according to the content of the broadcast message to prevent defibrillation in the body. When the device is used for treatment, repeated treatment results in wrong treatment.

在优选的方案中所述广播消息包含即将进行的电刺激治疗治疗的类型,所述电刺激类型为除颤时,所述体外除颤设备延迟启动诊断和治疗操作。In a preferred solution, the broadcast message includes the type of the electrical stimulation therapy to be performed, and when the electrical stimulation type is defibrillation, the external defibrillation device delays initiating diagnosis and therapy operations.

在优选的方案中,所述植入式心脏除颤器的处理器治疗完成后通过通信模块发送包含治疗完成信息的广播消息。In a preferred solution, the processor of the implantable cardiac defibrillator sends a broadcast message containing the treatment completion information through the communication module after the treatment is completed.

在优选的方案中,所述治疗完成的广播消息,包括患者是否恢复窦性心律;如果所述患者未恢复窦性心律则体外除颤设备立即进行除颤。In a preferred solution, the broadcast message of the completion of the treatment includes whether the patient has recovered sinus rhythm; if the patient has not recovered sinus rhythm, the external defibrillation device will defibrillate immediately.

在优选的方案中,所述治疗完成的广播消息,包括患者是否恢复窦性心律;如果所述患者未恢复窦性心律则体外除颤设备立即进行诊断,在所述诊断结果需要除颤时进行体外除颤。In a preferred solution, the broadcast message of the completion of the treatment includes whether the patient has recovered sinus rhythm; if the patient has not recovered sinus rhythm, the external defibrillation device will immediately diagnose, and the diagnosis will be performed when defibrillation is required. External defibrillation.

在优选的方案中,所述体外除颤设备包括用户接口,所述体外除颤设备处理器根据接收到的广播消息通过所述用户接口提示植入式心脏除颤器工作状态。In a preferred solution, the external defibrillation device includes a user interface, and the external defibrillation device processor prompts the working state of the implantable cardiac defibrillator through the user interface according to the received broadcast message.

在优选的方案中,所述用户接口包括可提供声音、光线、画面或震动反馈的电子部件。In a preferred solution, the user interface includes electronic components that can provide sound, light, picture or vibration feedback.

在上述方案中,对患者施加急救的急救人员能够通过体外除颤设备的用户接口快速知晓患者所处的状态,以及体内植入式心脏除颤器所处的状态,从而有效的帮助急救人员做出进一步施救的决定。In the above scheme, the emergency personnel who apply first aid to the patient can quickly know the state of the patient and the state of the implantable cardiac defibrillator through the user interface of the external defibrillation device, thereby effectively helping the emergency personnel to do make further rescue decisions.

在优选的方案中,所述处理器对于植入式心脏除颤器的不同工作状态,提供与所述工作状态对应声音画面光线同步提示信息。In a preferred solution, for different working states of the implantable cardiac defibrillator, the processor provides sound, picture, and light synchronization prompt information corresponding to the working state.

附图说明Description of drawings

图1是植入式心脏除颤器植入在人体内时状态示意图。FIG. 1 is a schematic diagram of the state of the implantable cardiac defibrillator when it is implanted in the human body.

图2是植入式心脏除颤器硬件模块结构示意图。FIG. 2 is a schematic structural diagram of a hardware module of an implantable cardiac defibrillator.

图3是体外除颤设备示意图。Figure 3 is a schematic diagram of an external defibrillation device.

图4是体外除颤设备硬件模块结构示意图。FIG. 4 is a schematic structural diagram of a hardware module of an external defibrillation device.

图5是植入式心脏除颤器与体外除颤设备通信流程示意图。FIG. 5 is a schematic diagram of a communication flow between an implantable cardiac defibrillator and an external defibrillation device.

具体实施方式Detailed ways

本发明提供一种植入式心脏除颤器和体外除颤设备联合系统。其包括植入式心脏除颤器和体外除颤设备。所述植入式心脏除颤器在适当的时机向体外除颤设备发送广播并且体外除颤设备在收到所述植入式心脏除颤器发送的广播后向做出相应的反应,例如通过用户接口发出提示,延迟感知治疗等。The invention provides a combined system of implantable cardiac defibrillator and external defibrillation equipment. It includes implantable cardiac defibrillators and external defibrillators. The implantable cardiac defibrillator sends a broadcast to the external defibrillation device at an appropriate time, and the external defibrillation device responds accordingly after receiving the broadcast sent by the implantable cardiac defibrillator, for example, by The user interface issues prompts, delays perception therapy, etc.

参照图1,图中所示为经静脉植入式心脏除颤器500。所述经静脉植入式心脏除颤器500包括设置在皮下的脉冲发生器502,和与脉冲发生器502连接的导线504。静脉植入式心脏除颤器502根据导线504植入部位的可分为单腔、双腔和三腔,对应的导线的数量也分为1根至3根。图5中所示为双腔除颤器,导线可通过头静脉、锁骨下静脉、上腔静脉S进入右心室V和右心房A 为双腔结构。在本领域中还包括单腔ICD,在单腔ICD中使用一根导线与心室连接,在所述导线上设置高压线圈用于在除颤时与脉冲发生器502形成回路。Referring to Figure 1, a transvenously implantable cardiac defibrillator 500 is shown. The transvenous implantable cardiac defibrillator 500 includes a pulse generator 502 arranged subcutaneously, and a lead 504 connected to the pulse generator 502 . The intravenous implantable cardiac defibrillator 502 can be divided into single-chamber, double-chamber and triple-chamber according to the implantation site of the lead 504, and the corresponding number of leads is also divided into one to three. The dual-chamber defibrillator is shown in Figure 5, and the leads can enter the right ventricle V and right atrium A through the cephalic vein, subclavian vein, and superior vena cava S. It is a dual-chamber structure. Also included in the art are single-chamber ICDs in which a lead is used to connect to the ventricle on which a high-voltage coil is placed to form a circuit with the pulse generator 502 during defibrillation.

所述导线504分为右心房导线508和右心室导线506,所述右心室导线 506末端与心脏组织o连接,用于感知心房信号。右心房导线508末端电极 510能够感知心房除极过程中产生的电信号即P波。The lead 504 is divided into a right atrium lead 508 and a right ventricle lead 506. The end of the right ventricle lead 506 is connected to the heart tissue o for sensing atrial signals. The electrode 510 at the end of the right atrial lead 508 can sense the P wave, an electrical signal generated during atrial depolarization.

所述右心室导线506分为与所述脉冲发生器502连接的近端以及与所述心脏组织o连接的远端。导线的末端包括与心脏组织o连接的螺旋电极512,螺旋电极512进入心脏组织o内将导线的前端与心脏组织固定。临近所导线506 的前端设置近场电极514,近场电极514用于感知近场心电信号,该近场心电信号反映心脏局部组织o去极化和复极过程。The right ventricular lead 506 is divided into a proximal end connected to the pulse generator 502 and a distal end connected to the cardiac tissue o. The end of the wire includes a helical electrode 512 connected to the heart tissue o, and the helical electrode 512 enters the heart tissue o to fix the front end of the wire with the heart tissue. A near-field electrode 514 is disposed adjacent to the front end of the lead 506, and the near-field electrode 514 is used to sense a near-field ECG signal, which reflects the depolarization and repolarization process of the local tissue of the heart.

所述右心室导线506的近端516与脉冲发生器502的连接器518连接。连接器518提供导线插入的电连接插孔,该连接器518内部包括馈通组件604,馈通组件604连接导线和脉冲发生器502的电路。馈通组件604通过导线连接感知电极,感知电极(电极512或电极514或心房电极)通过馈通组件604与脉冲发生器502内的感知模块602连接。感知模块602用于感知所述心电信号,并对心电信号作进一步处理使得心电信号由模拟信号转换为数字信号。所述馈通组件604将导线上感知电极与感知模块602连接。The proximal end 516 of the right ventricular lead 506 is connected to the connector 518 of the pulse generator 502 . The connector 518 provides electrical connection jacks into which the wires are inserted, and internally includes a feedthrough assembly 604 that connects the wires to the circuitry of the pulse generator 502 . The feedthrough assembly 604 is connected to the sensing electrodes through wires, and the sensing electrodes (electrode 512 or electrode 514 or atrial electrode) are connected to the sensing module 602 in the pulse generator 502 through the feedthrough assembly 604 . The sensing module 602 is used for sensing the ECG signal, and further processing the ECG signal so that the ECG signal is converted from an analog signal to a digital signal. The feed-through assembly 604 connects the sensing electrodes on the wires to the sensing module 602 .

所述连接器内518还包括天线606,天线606通过馈通组件604与脉冲发生器内的天线连接。所述天线606用于脉冲发生器502与外部设备建立无线连接通信连接。所述外部设备D包括医院使用的程控仪D,患者使用的手持设备比如手机、患者助手或医疗设备网关等设备。The connector 518 also includes an antenna 606 that is connected to the antenna in the pulse generator through the feed-through assembly 604 . The antenna 606 is used for establishing a wireless communication connection between the pulse generator 502 and an external device. The external device D includes a program controller D used by a hospital, a handheld device used by a patient, such as a mobile phone, a patient assistant, or a medical device gateway.

参照图2所示的脉冲发生器502内的硬件结构示意图。其包括用于感知心电信号的感知模块602,用于提供治疗脉冲信号的治疗模块608,用于与外部设备除颤设备通信的通信模块610。用于存储病人数据、参数以及诊疗程序代码的存储模块612,存储模块612可以包括RAM、ROM、闪存和/或其他存储电路。以及控制模块614进行诊疗程序,根据患者参数以及诊断程序设定对感知模块感知到的心电信号处理、分析,并根据诊断结果判断是否需要通过治疗模块608对心脏进行电刺激。Referring to the schematic diagram of the hardware structure in the pulse generator 502 shown in FIG. 2 . It includes a sensing module 602 for sensing electrocardiographic signals, a treatment module 608 for providing treatment pulse signals, and a communication module 610 for communicating with external equipment defibrillation equipment. A storage module 612 for storing patient data, parameters, and diagnostic procedure codes. The storage module 612 may include RAM, ROM, flash memory, and/or other storage circuits. And the control module 614 performs the diagnosis and treatment procedure, processes and analyzes the ECG signal sensed by the sensing module according to the patient parameters and the setting of the diagnosis procedure, and judges whether the heart needs to be electrically stimulated by the treatment module 608 according to the diagnosis result.

所述感知模块602与导线504上电极514、512连接,所述感知模块包括放大器、滤波器、数模转换模块等。感知模块602能够同时处理右心房导线 508和右心室导线506上的信号,并感知到的p波信号或R波信号转换成数字信号,所述处理器614利用所述P波或R波信号计算PR间期、AA间期、RR间期等生理参数。The sensing module 602 is connected to the electrodes 514 and 512 on the wire 504, and the sensing module includes an amplifier, a filter, a digital-to-analog conversion module, and the like. The sensing module 602 can simultaneously process the signals on the right atrial lead 508 and the right ventricular lead 506, and convert the sensed p-wave or R-wave signal into a digital signal, and the processor 614 uses the P-wave or R-wave signal to calculate Physiological parameters such as PR interval, AA interval, and RR interval.

所述通信模块610与天线606连接,通信模块610与体外除颤设备连接进行通信,通信模块优选的为医疗RF模块。本领域技术人员知道所述通信模块还包括WIFI、蓝牙、红外、超声波等本领域技术人员公知的通信模块。The communication module 610 is connected to the antenna 606, and the communication module 610 is connected to the external defibrillation equipment for communication. The communication module is preferably a medical RF module. Those skilled in the art know that the communication module further includes communication modules known to those skilled in the art, such as WIFI, Bluetooth, infrared, ultrasonic, etc.

所述治疗模块608包括开关电路,所述治疗模块608包括开关电路,进行电刺激时控制模块控制所述开关电路治疗模块形成电刺激回路,所述控制模块可控制治疗模块进行抗心动过速治疗。The treatment module 608 includes a switch circuit, and the treatment module 608 includes a switch circuit. When performing electrical stimulation, the control module controls the switch circuit treatment module to form an electrical stimulation circuit, and the control module can control the treatment module to perform anti-tachycardia treatment. .

所述植入式心脏除颤器500为除颤器或心律复转除颤器时,所述治疗模块 608还包括高压电容和对高压电容充电的高压电路,所述高压电路在除颤治疗前对高压电容充电,所述高压电路在被配置为按照不同的治疗需求,对所属高压电容冲入不同能量的电能,高压电容的能量维持在20J-40J范围内。When the implantable cardiac defibrillator 500 is a defibrillator or a cardioverter-defibrillator, the treatment module 608 further includes a high-voltage capacitor and a high-voltage circuit for charging the high-voltage capacitor. The high-voltage circuit is used before defibrillation therapy. To charge the high-voltage capacitor, the high-voltage circuit is configured to charge the high-voltage capacitor with different energies according to different treatment requirements, and the energy of the high-voltage capacitor is maintained in the range of 20J-40J.

植入式心脏除颤器500和体外除颤设备联合系统中的体外除颤设备为如图 1所示的全自动体外除颤器(AED),显然所述体外除颤设备还可以是穿戴式体外心脏除颤器。The external defibrillation device in the combined system of implantable cardiac defibrillator 500 and external defibrillation device is an automatic external defibrillator (AED) as shown in FIG. 1 . Obviously, the external defibrillation device may also be a wearable device. External defibrillator.

如图1所示,所属体外除颤设备300包括用于贴敷在人体上的除颤/感知电极312、314,所述电极通过导线318与AED的脉冲发生器316连接,所述脉冲发生器316包括一开关按钮320和一电击按钮322。电极312、314与人体连接后所述开关按钮320开机并开始自动分析患者所处状态,并根据患者状态给出是否电击的建议,并给出操作提示。通常而言所述操作提示会提示急救人员或其他人员不与患者有物理接触,并且再保证没有物理接触的情况下触发电击按钮。As shown in FIG. 1 , the external defibrillation device 300 includes defibrillation/sensing electrodes 312 and 314 for sticking on the human body, and the electrodes are connected to the pulse generator 316 of the AED through a wire 318 , and the pulse generator 316 includes a switch button 320 and a shock button 322. After the electrodes 312 and 314 are connected to the human body, the switch button 320 is turned on and starts to automatically analyze the state of the patient, and gives a suggestion for electric shock according to the patient's state, and gives an operation prompt. Generally speaking, the operation prompt will prompt emergency personnel or other personnel not to have physical contact with the patient, and then ensure that the shock button is triggered without physical contact.

参照图3所述体外除颤设备300包括电源304、通信模块306、治疗模块 308和处理器302模块。所述处理器302通过通信模块306与所述植入式心脏除颤器500通信,所述通信模块306优选地通过WIFI、蓝牙、RF、超声波等无线通信方式建立通信链路,所述通信链路用于接收植入式心脏除颤器的广播信号。The external defibrillation device 300 described with reference to FIG. 3 includes a power supply 304, a communication module 306, a therapy module 308, and a processor 302 module. The processor 302 communicates with the implantable cardiac defibrillator 500 through the communication module 306. The communication module 306 preferably establishes a communication link through wireless communication methods such as WIFI, Bluetooth, RF, and ultrasound. The channel is used to receive the broadcast signal of the implantable cardiac defibrillator.

所述治疗模块308包括高压电路,高压电路包括变压器和高压电容。变压器和相应的驱动电路用于将电源304的电压升压为除颤电压,所述变压器升压后向高压电容电压为700-800v,所述高压电容能量为120J-360J。所述高压电容充电并对人体放电除颤,所述体外除颤设备300放电过程包括双向或单向放电。所述治疗模块308与电极贴片312、314连接,所述放电过程在电极贴片 312、314高压电容和人体组成的回路中完成。The therapy module 308 includes a high voltage circuit including a transformer and a high voltage capacitor. The transformer and the corresponding driving circuit are used for boosting the voltage of the power supply 304 to a defibrillation voltage, the voltage of the high-voltage capacitor after the boosting of the transformer is 700-800V, and the energy of the high-voltage capacitor is 120J-360J. The high-voltage capacitor is charged and discharged to defibrillate the human body, and the discharge process of the external defibrillation device 300 includes bidirectional or unidirectional discharge. The treatment module 308 is connected to the electrode patches 312, 314, and the discharge process is completed in a loop composed of the electrode patches 312, 314 high-voltage capacitors and the human body.

所述体外除颤设备300还包括感知模块310和存储模块316,该感知模块 310用于将体表心电信号转换为数字信号。所述体外除颤设备300还包括用于感知体表心电信号的感知电极312、314,感知电极与所述感知模块304连接。所述处理器302通过感知模块310感知到的心电信号并分析所述心电信号诊断患者所处的状态。The external defibrillation device 300 further includes a sensing module 310 and a storage module 316, and the sensing module 310 is used to convert the electrocardiographic signal of the body surface into a digital signal. The external defibrillation device 300 further includes sensing electrodes 312 and 314 for sensing electrocardiographic signals on the body surface, and the sensing electrodes are connected to the sensing module 304 . The processor 302 diagnoses the state of the patient by analyzing the ECG signal sensed by the sensing module 310 and analyzing the ECG signal.

所述体外除颤设备300还包括人机接口模块。所述人机接口模块用于向急救人员提供操作接口,如上文所述的按键320。以及用于向急救人员反馈信息的显示器328、扬声器、指示器或振动模块等用于向急救人员提供声音、光线、画面或震动反馈的电子部件。The external defibrillation device 300 further includes a human-machine interface module. The man-machine interface module is used to provide an operation interface for emergency personnel, such as the button 320 described above. And electronic components such as a display 328, a speaker, an indicator or a vibration module for providing feedback to the emergency personnel for providing sound, light, picture or vibration feedback to the emergency personnel.

参照图4所示的植入式心脏除颤器与体外除颤设备300通信流程示意图。在步骤804和步骤802中,所述植入式心脏除颤器500进行初始化。所述植入式心脏除颤器初始化包括通过程控仪D设置初始化参数,所述体外除颤设备 300初始化包括开机,感知电极312、314的导通性,监测胸部阻抗等基本参数。Referring to the schematic flowchart of the communication between the implantable cardiac defibrillator and the external defibrillation device 300 shown in FIG. 4 . In steps 804 and 802, the implantable cardiac defibrillator 500 is initialized. The initialization of the implantable cardiac defibrillator includes setting initialization parameters through the process controller D, and the initialization of the external defibrillation device 300 includes turning on the device, sensing the continuity of the electrodes 312 and 314, and monitoring basic parameters such as chest impedance.

在步骤808中在该流程中感知模块602通过感知电极512和电极514感知心电信号,所述心电信号是心内电信号,或感知电极512、514感知心电信号并将其转换为数字信号,用于处理器614处理。In step 808, the sensing module 602 senses the ECG signal through the sensing electrode 512 and the electrode 514, and the ECG signal is an intracardiac electric signal, or the sensing electrodes 512, 514 sense the ECG signal and convert it into a digital signal signal for processing by processor 614.

在步骤810中,处理器614通过诊断算法诊断是否存发生恶性心律事件。所述处理器614根据患者心律的突发性、间期异变性、平均心律和QRS波形形态等方法判断患者是否发生了室颤、室速等恶性心率事件,并且通过这些算法将室颤、室速等恶性心律事件与房颤、房扑、窦性心律等室上性心动过速进行区分以防止发生误电击。以判断室颤为例,可通过设置观察窗口的方式检测是否发生室颤,例如设置18/24窗口门限值作为发生室颤的判断标准。当然在判断是否发生室颤还可以结合心音、血压、血流、运动传感器综合判断是否发生了室颤,例如通过血流流量判断是否发生室颤、通过运动传感器判断患者身体姿态(例如判断患者是否晕厥和评估患者生理活动水平)。In step 810, the processor 614 diagnoses the presence or absence of a malignant cardiac rhythm event through a diagnostic algorithm. The processor 614 judges whether the patient has a malignant heart rate event such as ventricular fibrillation and ventricular tachycardia according to methods such as the suddenness of the patient's heart rhythm, interval variability, average heart rhythm and QRS waveform shape, etc. Malignant heart rhythm events such as tachycardia are distinguished from supraventricular tachycardia such as atrial fibrillation, atrial flutter, and sinus rhythm to prevent false shocks. Taking the judgment of ventricular fibrillation as an example, the occurrence of ventricular fibrillation can be detected by setting an observation window, for example, setting a threshold value of 18/24 window as the judgment standard of ventricular fibrillation. Of course, when judging whether ventricular fibrillation occurs, heart sounds, blood pressure, blood flow, and motion sensors can be combined to comprehensively determine whether ventricular fibrillation has occurred. syncope and assess the patient's physical activity level).

如果在步骤810中判断未发生恶性心律失常则返回步骤808,否则进入步骤812。在步骤812中,发现恶性心律所述处理器614控制植入心脏除颤器进入准备电刺激治疗的状态。在该状态中所述处理器614控制治疗模块对电容进行充电。在充电前或电过程中所述处理器通过通信模块610广播消息。该广播消息包含即将实施的治疗消息。根据步骤810的分析结果所述即将实施的电刺激治疗包括起搏、抗心动过速起搏、低能量除颤以及高能量除颤。If it is determined in step 810 that no malignant arrhythmia has occurred, go back to step 808 , otherwise, go to step 812 . In step 812, when a malignant heart rhythm is found, the processor 614 controls the implanted cardiac defibrillator into a state ready for electrical stimulation therapy. In this state the processor 614 controls the therapy module to charge the capacitor. The processor broadcasts a message through the communication module 610 before or during charging. The broadcast message contains information about the treatment to be administered. According to the analysis results of step 810, the electrical stimulation therapy to be implemented includes pacing, anti-tachycardia pacing, low-energy defibrillation, and high-energy defibrillation.

在步骤814中所述处理器614控制治疗模块608释放电刺激治疗,并可在电刺激治疗后或电刺激治疗前发送广播消息,所述广播消息包括当前正在进行电刺激的类型。In step 814, the processor 614 controls the therapy module 608 to release the electrical stimulation therapy, and may send a broadcast message after the electrical stimulation therapy or before the electrical stimulation therapy, the broadcast message including the type of electrical stimulation currently being performed.

在电刺激治疗完成后控制流程回到步骤810,在步骤810中根据刺激后的心电信号的监测结果判断是否治疗是否成功恢复窦性心律。在步骤810中电刺激完成后通过处理器614分析心电信号是否分析窦性心律。如果恢复窦性心律则通过通信模块610向外部广消息,该消息中包括恢复窦性心律信息和治疗完成信息。After the electrical stimulation treatment is completed, the control flow returns to step 810, and in step 810, it is determined whether the treatment is successful in restoring sinus rhythm according to the monitoring result of the stimulated ECG signal. After the electrical stimulation is completed in step 810, the processor 614 analyzes whether the ECG signal is to be analyzed for sinus rhythm. If the sinus rhythm is restored, a message is sent to the outside through the communication module 610, and the message includes the information on the restoration of the sinus rhythm and the completion of the treatment.

在步骤标号为816、818、820、822、824的步骤中,所述体外除颤设备 300的处理器302根据消息的内容类型作出不同的处理并执行不同的操作。在步骤802初始化完成后所述体外除颤设备300的处理器302设置计时器,所述计时器设置处理器等待广播消息的时间,计时器的时间应当设置的较短以防止过长的等待时间延误之治疗时机,例如在设置等待500毫秒至1秒时间后超时。在步骤826中判断如果经过设置的超时时限后,并且在步骤806中没有收到广播消息,所述控制流程进入步骤828。进入步骤828后体外除颤设备开始在步骤828中监测心电信号,在步骤830中所体外除颤设备300分析心电信号,并根据心电信号的分析结果判断是否发生恶性心律。在步骤832中判断发生恶性心律后所述体外除颤设备300在步骤834中进行除颤治疗,并在在治疗完成后重新回到步骤828监测,除颤治疗是否成功。如果在步骤832中判断未发生恶性性心律,则直接进入步骤824结束整个体外除颤设备300的控制控制流程。In the steps numbered 816, 818, 820, 822, and 824, the processor 302 of the external defibrillation device 300 performs different processing and performs different operations according to the content type of the message. After the initialization in step 802 is completed, the processor 302 of the external defibrillation device 300 sets a timer, and the timer sets the time for the processor to wait for the broadcast message, and the time of the timer should be set short to prevent excessive waiting time Delayed treatment timing, such as setting a timeout after 500ms to 1 second. It is determined in step 826 that if the set timeout period has elapsed and no broadcast message is received in step 806 , the control flow proceeds to step 828 . After entering step 828, the external defibrillation device starts to monitor the ECG signal in step 828. In step 830, the external defibrillation device 300 analyzes the ECG signal and determines whether a malignant heart rhythm occurs according to the analysis result of the ECG signal. After it is determined in step 832 that a malignant heart rhythm occurs, the external defibrillation device 300 performs defibrillation treatment in step 834, and returns to step 828 after the treatment is completed to monitor whether the defibrillation treatment is successful. If it is determined in step 832 that no malignant heart rhythm has occurred, then directly enter step 824 to end the control flow of the entire external defibrillation device 300 .

在步骤806中如果体外除颤设备300的处理器302通过通信模块306收到植入式心脏除颤器500发送的广播消息。所述广播消息可选的包括设备的状态、即将进行的治疗、正在进行的治疗、治疗是否完成、以及治疗结果是否恢复窦性心律、患者的活动数据等植入式心脏除颤器能够监测、处理和存储的各种信息。In step 806 , if the processor 302 of the external defibrillation device 300 receives the broadcast message sent by the implantable cardiac defibrillator 500 through the communication module 306 . The broadcast message can optionally include the status of the device, the upcoming treatment, the ongoing treatment, whether the treatment is completed, and whether the treatment result restores sinus rhythm, the patient's activity data, etc. The implantable cardiac defibrillator can monitor, Various information processed and stored.

在步骤816中处理器302首先判断所述广播消息中电刺激治疗消息,判断电刺激治疗消息是否指示植入式心脏除颤器500是否正在进行准备治疗,如果所述植入式心脏除颤设备500正在电刺激治疗的准备阶段,所述体外除颤设备300延迟治疗,控制流程回到步骤806继续接收所述植入式心脏除颤器500的广播消息。In step 816, the processor 302 first judges the electrical stimulation therapy message in the broadcast message, and judges whether the electrical stimulation therapy message indicates whether the implantable cardiac defibrillator 500 is preparing for treatment. 500 is in the preparation stage of the electrical stimulation therapy, the external defibrillation device 300 delays the therapy, and the control flow returns to step 806 to continue to receive the broadcast message of the implantable cardiac defibrillator 500 .

如果所述广播消息未指示所述植入式心脏除颤器,正在准备除颤设备,则体外除颤设备300处理器在步骤818中判断其是否正在电刺激治疗,所述电刺激治疗的类型可包括除颤、抗心动过速起搏、起搏和多能量等级的除颤。如果植入式心脏除颤器500正在进行除颤,所述体外除颤设备300延迟对患者检测和治疗,控制流程回到步骤806。If the broadcast message does not indicate that the implantable cardiac defibrillator is preparing a defibrillation device, the external defibrillator device 300 processor determines in step 818 whether it is undergoing electrical stimulation therapy, the type of electrical stimulation therapy May include defibrillation, antitachycardia pacing, pacing, and defibrillation at multiple energy levels. If the implantable cardiac defibrillator 500 is defibrillating, the external defibrillation device 300 delays detection and treatment of the patient, and the control flow returns to step 806 .

如果在步骤818中判断植入式心脏除颤器500不在治疗过程中,则进入步骤820判断是否治疗完成。如果所述植入式心脏除颤器500治疗完成,植入式心脏除颤器的步骤810中,植入式心脏除颤器处理器500在治疗完成后通过通信模块610向体外除颤设备300发送包含治疗完成消息的广播消息。所述治疗完成的广播消息可包括患者治疗是否完成的消息,以及植入式心脏除颤器的治疗结果。If it is determined in step 818 that the implantable cardiac defibrillator 500 is not in the treatment process, then go to step 820 to determine whether the treatment is completed. If the treatment of the implantable cardiac defibrillator 500 is completed, in step 810 of the implantable cardiac defibrillator, the implantable cardiac defibrillator processor 500 sends the external defibrillation device 300 through the communication module 610 after the treatment is completed. Send a broadcast message containing the treatment complete message. The broadcast message of completion of the treatment may include a message of whether the treatment of the patient is completed, and the treatment result of the implantable cardiac defibrillator.

在步骤822中体外除颤设备300的处理器302根据体植入式心脏除颤器 500的治疗结果判断患者是否恢复了窦性心律,如果患者恢复了窦性心律则体外除颤设备300直接进入结束步骤824。In step 822, the processor 302 of the external defibrillation device 300 determines whether the patient has recovered sinus rhythm according to the treatment result of the implantable cardiac defibrillator 500. If the patient has recovered sinus rhythm, the external defibrillation device 300 directly enters the End step 824.

所述广播消息还可以包括患者正在进行的心电信号,该心跳信号为实时心跳信号或历史数据,为一段连续的数据也可以是某一数据片段。在步骤822中体外设备的处理器可以根据所述心电信号判断患者是否恢复窦性心律。The broadcast message may also include the ongoing ECG signal of the patient, and the heartbeat signal may be a real-time heartbeat signal or historical data, and may be a continuous piece of data or a certain data segment. In step 822, the processor of the extracorporeal device may determine whether the patient has recovered sinus rhythm according to the ECG signal.

在步骤822中,如果根据植入式心脏除颤器500的治疗结果或植入式心脏除颤器500发送的心电信号诊断患者未恢复窦性心律则体外除颤设备300立即进行诊断,控制流程转到步骤828,并根据步骤832的结果在需要除颤时进行体外除颤。In step 822, if it is diagnosed that the patient has not recovered sinus rhythm according to the treatment result of the implantable cardiac defibrillator 500 or the ECG signal sent by the implantable cardiac defibrillator 500, the external defibrillation device 300 immediately performs a diagnosis, and controls Flow proceeds to step 828, and according to the result of step 832, external defibrillation is performed when defibrillation is required.

本领域技术人员知道,在步骤822中如果未恢复窦性心律控制流程还可以跳转至834直接进行除颤治疗,相对所述植入式心脏除颤器,体外除颤设备 300具有更高的除颤能量。当植入式心脏除颤器除颤能量已经达到最高能量仍然无法恢复窦性心律,立即进行体外除颤的尝试能提高除颤成功的可能性。Those skilled in the art know that if the sinus rhythm control process is not restored in step 822, the process can be jumped to 834 to directly perform defibrillation treatment. Compared with the implantable cardiac defibrillator, the external defibrillation device 300 has a higher Defibrillation energy. When the defibrillation energy of the implantable cardiac defibrillator has reached the highest energy and still cannot restore sinus rhythm, the attempt to perform external defibrillation immediately can improve the probability of successful defibrillation.

在上述方案中所述体外除颤设备300的处理器通过通信模块接收到所述植入式体除颤设备发送的广播消息后根据广播消息的内容,执行相应的操作。根据植入式心脏除颤器所处的状态和输出的结果进行操作。总体而言如果植入式心脏除颤器正在准备电刺激治疗或正在进行电刺激治疗,所述体外除颤设备 300则延迟诊断和治疗等待所述植入式心脏除颤器完成治疗。并且如果植入式心脏除颤器治疗设备治疗失败,所述体外除颤设备300也能够及时的进入诊断和治疗的状态,所述体外除颤设备300可相对植入式心脏除颤器提供更高的除颤能量提供从而增大救治的成功率。In the above solution, the processor of the external defibrillation device 300 performs corresponding operations according to the content of the broadcast message after receiving the broadcast message sent by the implantable body defibrillator device through the communication module. Operates according to the state and output of the implantable cardiac defibrillator. In general, if the implantable cardiac defibrillator is preparing for electrical stimulation therapy or is undergoing electrical stimulation therapy, the external defibrillator device 300 delays diagnosis and therapy until the implantable cardiac defibrillator completes the therapy. And if the implantable cardiac defibrillator treatment device fails, the external defibrillation device 300 can also enter the state of diagnosis and treatment in a timely manner, and the external defibrillation device 300 can provide better performance than the implantable cardiac defibrillator. High defibrillation energy is provided to increase the success rate of treatment.

参照图5所示的模块结构图,其中包括控制模块400和人机接口模块。所述控制模块800为包括部分图4中所示的逻辑流程步骤模块,其被定义为多个步骤的集合。在本申请中所述人机接口模块用于在所述逻辑流程模块中起到为急救人员提供信息或接受急救人员输入的功能。同时所述体外除颤设备300处理器302根据接收到的广播消息通过所述用户接口提示植入式心脏除颤器工作状态。Referring to the module structure diagram shown in FIG. 5 , it includes a control module 400 and a human-machine interface module. The control module 800 is a module that includes parts of the logic flow steps shown in FIG. 4, which are defined as a collection of steps. The human-machine interface module described in the present application is used in the logic flow module to play a function of providing information for emergency personnel or accepting input from emergency personnel. At the same time, the processor 302 of the external defibrillation device 300 prompts the working state of the implantable cardiac defibrillator through the user interface according to the received broadcast message.

所述处理器302对于植入式心脏除颤器的不同工作状态,提供与所述工作状态对应声音画面光线同步提示信息。所述语音提示消息The processor 302 provides, for different working states of the implantable cardiac defibrillator, prompt information synchronously with sound, picture, and light corresponding to the working state. the voice prompt message

参照图5在初始化802过程中,所述人机接口模块900发出基本信息提示 840,所述基本信息提示包括但不限于语音开机提示、语音操作提示、注意事项警报提示、带有显示屏幕328的体外除颤设备300还可以进行与所述语音操作提示同步画面提示,例如通过显示器显示一段动画动画中包括如何拆开电极包装,如何将电极312、314贴在患者的胸部表面。Referring to FIG. 5 in the process of initialization 802, the man-machine interface module 900 sends out basic information prompts 840, the basic information prompts include but are not limited to voice boot prompts, voice operation prompts, precautions alarm prompts, and display screen 328. The external defibrillation device 300 can also perform screen prompts in synchronization with the voice operation prompts, for example, displaying an animation on the display including how to unpack the electrodes and how to attach the electrodes 312 and 314 to the patient's chest surface.

在步骤806中,体外除颤设备300收到广播消息后可通过人机接口模块提示患者基本信息842,所述患者基本信息可包括是否植入ICD、ICD所处的状态、患者所处的状态。例如所述如果所述广播消息表面患者植入的心脏除颤器正在诊断,体外除颤设备300可通过声画同步的方式告知急救人员所述植入式心脏除颤器正在进行诊断等消息。In step 806, after receiving the broadcast message, the external defibrillation device 300 may prompt the patient's basic information 842 through the human-machine interface module, and the patient's basic information may include whether the ICD is implanted, the state of the ICD, and the state of the patient. . For example, if the broadcast message indicates that the patient's implanted cardiac defibrillator is being diagnosed, the external defibrillation device 300 may notify the emergency personnel that the implanted cardiac defibrillator is being diagnosed by means of sound and picture synchronization.

在步骤816中,体外除颤设备300通过人机接口模块900步骤844提示设备正在处于充电状态。所述提示信息可包括充电进度、充电能量、充电剩余时间,以及以何种方式进行治疗。In step 816, the external defibrillation device 300 notifies through the human-machine interface module 900 of step 844 that the device is in a charging state. The prompt information may include charging progress, charging energy, remaining charging time, and the mode of treatment.

在步骤818中,体外除颤设备300收到广播消息后确定植入式心脏除颤器正在进行电刺激治疗。人机结构模块通过模块846提示设备处于电刺激治疗状态,所述体外除颤设备300通过声画同步的方式告知急救人员植入式心脏除颤器正在进行治疗,并且可发出一定的警告提示例如此时不要移动患者。In step 818, after receiving the broadcast message, the external defibrillation device 300 determines that the implantable cardiac defibrillator is undergoing electrical stimulation therapy. The human-machine structure module prompts the device to be in the state of electrical stimulation treatment through the module 846, the external defibrillation device 300 informs the emergency personnel that the implanted cardiac defibrillator is undergoing treatment by means of sound and picture synchronization, and can issue certain warning prompts such as Do not move the patient at this time.

在步骤820中,体外除颤设备300发出提示完成848。例如人机接口可通过扬声器发出"治疗完成即将进行除颤后诊断"等语音提示信息。同时可提示急救人员继续等待等信息。In step 820, the external defibrillation device 300 issues a prompt 848 to complete. For example, the human-machine interface can issue voice prompts such as "the treatment is completed and the diagnosis after defibrillation is about to be carried out" through the speaker. At the same time, it can prompt emergency personnel to continue to wait and other information.

在步骤822中,所述人机接口发出报告患者状态信息859,如果患者已经恢复窦性心律,可通过该信息告知急救人员患者心律已经恢复正常,并可提示在患者苏醒后或意识恢复正常后撤除体外除颤设备300。如果患者未恢复窦性心律,则提示体外除颤设备300即将进行诊断治疗,分析患者的心电图,并提示急救人员根据体外除颤设备300的提示进行操作。In step 822, the man-machine interface sends out report patient status information 859. If the patient has recovered sinus rhythm, the information can be used to inform the emergency personnel that the patient's heart rhythm has returned to normal, and it can be prompted that after the patient wakes up or his consciousness returns to normal The external defibrillation device 300 is removed. If the patient does not restore sinus rhythm, the external defibrillation device 300 is prompted to perform diagnosis and treatment, the patient's electrocardiogram is analyzed, and emergency personnel are prompted to operate according to the prompt of the external defibrillation device 300 .

在步骤824中,人机接口可发出结束提示852,该结束提示可包括体外除颤设备300如何收纳,如何检查体外除颤设备300的参数和状态,如何排除故障以及如何通过紧急联系方式联系到设备厂家。In step 824, the human-machine interface may issue an end prompt 852, which may include how to store the external defibrillation device 300, how to check the parameters and status of the external defibrillation device 300, how to troubleshoot, and how to contact the external defibrillator through emergency contact information. equipment manufacturers.

在上述方案中体外除颤设备300通过人机接口能够对植入式心脏除颤器所处的状态,进行提示使得在诊断、治疗等时刻急救人员都能明确知道植入式心脏除颤器所处的状态。急救人员也能够知道体外除颤设备300在植入式医疗进行治疗或除颤时会延迟治疗,同时如果植入式心脏除颤器也能在植入式心脏除颤器除颤失败时及时介入提高救治的成功率。In the above solution, the external defibrillation device 300 can prompt the state of the implantable cardiac defibrillator through the human-machine interface, so that the emergency personnel can clearly know the status of the implantable cardiac defibrillator at the time of diagnosis, treatment, etc. status. The emergency personnel can also know that the external defibrillation device 300 will delay the treatment when the implantable medical treatment or defibrillation is performed, and at the same time, if the implantable cardiac defibrillator can also intervene in time when the defibrillation of the implantable cardiac defibrillator fails Improve the success rate of treatment.

Claims (8)

1.植入式心脏除颤器和体外除颤设备联合系统,其特征在于,包括植入式心脏除颤器和体外除颤设备;所述植入式心脏除颤器包括处理器、感知模块、治疗模块和通信模块;所述体外除颤设备包括处理器、感知模块、治疗模块和通信模块;所述植入式心脏除颤器的处理器被配置为根据其感知模块感知到的心电信号诊断是否需要电刺激治疗,所述植入式心脏除颤器的处理器再使用其治疗模块对心脏进行电刺激治疗前,使用其通信模块发送广播消息,该广播消息包含处理器即将实施的治疗信息;1. implanted cardiac defibrillator and external defibrillation equipment combined system, is characterized in that, comprises implanted cardiac defibrillator and external defibrillation equipment; Described implanted cardiac defibrillator comprises processor, perception module , a treatment module and a communication module; the external defibrillation device includes a processor, a sensing module, a treatment module and a communication module; the processor of the implantable cardiac defibrillator is configured to sense the ECG according to the sensing module Signal to diagnose whether electrical stimulation therapy is needed, and before the processor of the implantable cardiac defibrillator uses its therapy module to perform electrical stimulation therapy on the heart, it uses its communication module to send a broadcast message, and the broadcast message contains the information that the processor is about to implement. treatment information; 所述体外除颤设备的处理器通过其通信模块接收到所述植入式体心脏除颤器发送的广播消息后根据广播消息的内容,执行相应的操作。The processor of the external defibrillation device performs corresponding operations according to the content of the broadcast message after receiving the broadcast message sent by the implantable body cardiac defibrillator through its communication module. 2.根据权利要求1所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述广播消息包含即将进行的电刺激治疗治疗的类型,所述电刺激类型为除颤时,所述体外除颤设备延迟启动诊断和治疗操作。2. The implantable cardiac defibrillator and external defibrillator combined system according to claim 1, wherein the broadcast message includes the type of the upcoming electrical stimulation therapy, and the electrical stimulation type is a During fibrillation, the external defibrillation device delays initiating diagnostic and therapeutic operations. 3.根据权利要求2所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述植入式心脏除颤器的处理器治疗完成后通过通信模块发送包含治疗完成信息的广播消息。3. implanted cardiac defibrillator and external defibrillation equipment combined system according to claim 2, is characterized in that, after the processor treatment of described implanted cardiac defibrillator is completed, send through the communication module that includes treatment is completed Information broadcast message. 4.根据权利要求3所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述治疗完成信息的广播消息,包括患者是否恢复窦性心律;如果所述患者未恢复窦性心律则体外除颤设备立即进行除颤。4. The implanted cardiac defibrillator and external defibrillator combined system according to claim 3, wherein the broadcast message of the treatment completion information includes whether the patient restores sinus rhythm; if the patient does not Restoration of sinus rhythm results in immediate defibrillation by the external defibrillator. 5.根据权利要求3所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述治疗完成信息的广播消息,包括患者是否恢复窦性心律;如果所述患者未恢复窦性心律则体外除颤设备立即进行诊断,在所述诊断结果需要除颤时进行体外除颤。5. The implanted cardiac defibrillator and external defibrillator combined system according to claim 3, wherein the broadcast message of the treatment completion information includes whether the patient restores sinus rhythm; if the patient does not When sinus rhythm is restored, the external defibrillation device makes a diagnosis immediately, and external defibrillation is performed when the diagnosis requires defibrillation. 6.根据权利要求1所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述体外除颤设备包括用户接口,所述体外除颤设备的处理器根据接收到的广播消息通过所述用户接口提示植入式心脏除颤器工作状态。6. The combined system of implantable cardiac defibrillator and external defibrillation device according to claim 1, characterized in that, the external defibrillation device comprises a user interface, and the processor of the external defibrillation device according to the received The broadcast message prompts the working status of the implantable cardiac defibrillator through the user interface. 7.根据权利要求6所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述用户接口包括可提供声音、光线、画面或震动反馈的电子部件。7 . The combined system of implantable cardiac defibrillator and external defibrillation equipment according to claim 6 , wherein the user interface comprises an electronic component that can provide sound, light, picture or vibration feedback. 8 . 8.根据权利要求6所述的植入式心脏除颤器和体外除颤设备联合系统,其特征在于,所述体外除颤设备的处理器对于植入式心脏除颤器的不同工作状态,提供与所述工作状态对应声音画面光线同步提示信息。8. The combined system of implantable cardiac defibrillator and external defibrillation device according to claim 6, wherein the processor of the external defibrillation device has different working states for the implantable cardiac defibrillator, Provide sound, picture and light synchronization prompt information corresponding to the working state.
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